COMPANY NEWS

COMPANY NEWS; GENENTECH TO SEEK CLEARANCE FOR CYSTIC-FIBROSIS DRUG

Published: December 3, 1992

Genentech Inc. said yesterday that it had completed the final phase of human clinical trials of Pulmozyme, a new drug to treat cystic fibrosis. The company said that by March it would ask the Food and Drug Administration for clearance to market the drug. The results of the 968-patient study demonstrated that Pulmozyme, which is used in an aerosol form, improved lung function and reduced the rate of respiratory infection in patients with cystic fibrosis. No major adverse side effects were noted. The clinical data must still proceed through scientific and regulatory review.

Cystic fibrosis is the most common fatal genetic disease in the United States. It causes thick lung secretions that cause impaired breathing, frequent lung infections and continual degeneration of lung function. Median survival for a cystic fibrosis patient is 29 years. About 30,000 Americans, 3,000 Canadians and 20,000 Europeans are afflicted with the disease.